1. Pharmaceutical Industry Part I & II PHCL 311 Hadeel Al-Kofide M.Sc

2. Topics to be covered today.. Introduction Jobs opportunities in pharmaceutical industry History Definitions Types of interactions with industry profession Guidance to interactions with industry professions Other careers in pharmaceutical industry Market Leaders in Pharmaceutical Industry Deciding if pharmaceutical industry is suitable for you

3. Why Study Pharmaceutical Industry “We are all members of the pharmaceutical industry – we either prescribe drugs, or take them ourselves. We need to learn to work together.”

4. Introduction The pharmaceutical industry develops, produces, & markets medicinal drugs Pharmaceutical companies can deal in generic &/or brand medications They are subject to a variety of laws & regulations regarding the patenting, testing & marketing of drugs

5. It includes many job opportunities of pharmacists: Drug discovery Manufacturing Marketing Medical information Product development Quality assurance Training & development Sales Regulatory Project management Health outcomes research Legal Information technology Scientific communications Jobs Opportunities in Pharmaceutical Industry

7. History The earliest drugstores date back to the Middle Ages The first known drugstore was opened by Arabian pharmacists in Baghdad in & many more soon began operating throughout the medieval Islamic world & eventually medieval Europe By the 19th century, many of the drug stores in Europe & North America had eventually developed into larger pharmaceutical companies

8. History Most of today's major pharmaceutical companies were founded in the late 19th & early 20th centuries Key discoveries of the 1920s & 1930s, such as insulin & penicillin, became mass-manufactured & distributed Switzerland, Germany & Italy had particularly strong industries, with the UK, US, Belgium & the Netherlands following suit

9. Definitions Clinical research professionals Drug safety professionals Medical or drug information specialists Pharmaceutical sales representative (PSRs) PhRAM Pharmaceutical company Pharmaceutical products Detailing Drug discovery Drug development Pharmacovigilence

10. Clinical Research Professionals Responsible for the oversight of clinical trials Include clinical research monitors & administrators These two could be separated so the research monitors visit the site to complete data verification, & administrators will act as the link external to internal team members Definitions

11. Drug Safety Professionals Monitor serious adverse events & respond to Medwatch Responsible for global safety surveillance Also responsible for post-marketing surveillance Definitions

12. Medical or Drug Information Specialists Will address specific questions by patients & health care professionals that require review of data on file or address topics not directly related to the marketing mission Definitions

13. Pharmaceutical Sales Representative (PSRs) Have the primary responsibility of reaching out to providers & prescribers within a defined area These professionals deliver the marketing message for pharmaceutical products based on training received by the pharmaceutical manufacturer Definitions

14. PhRMA Pharmaceutical Research & Manufacturers of America Non-profit association that represents leading research based pharmaceutical & biotechnology companies Definitions

15. Pharmaceutical Company Manufacturer or sponsor The company who develops, manufacturers & supplies medication for patients Definitions

16. Pharmaceutical Products Drug therapies developed by pharmaceutical companies Also called pharmaceuticals Definitions

17. Detailing Occurs when a PSR meets with a health care practitioner to deliver their marketing message & provide product details Definitions

18. Medical Liaisons (MLs) A healthcare consulting professional who is employed by pharmaceutical, biotechnology, medical device, & managed care companies The ML is a person who can communicate high scientific concepts, yet balance clinical objectives with business opportunities Have the responsibility to build relationship with key health practitioners (i.e. leaders) Definitions

19. Drug Discovery The process by which potential drugs are discovered In the past most drugs have been discovered by isolating the active ingredient from traditional remedies Modern technology focus on understanding metabolic pathways related to disease state or pathogen, & manipulating these pathways using molecular biology or biochemistry A great deal of early-stage drug discovery has traditionally been carried out by universities & research institutions Definitions

20. Drug Development Refers to activities undertaken after a compound is identified as a potential drug in order to establish its suitability as a medication Objectives of drug development are to determine appropriate formulation & dosing, as well as to establish safety Research in these areas generally includes a combination of in vitro studies, in vivo studies, & clinical trials Definitions

21. Pharmacovigilence Also called safety surveillance The monitoring of adverse events for a pharmaceutical product Definitions

22. Types of Interactions With Industry Professionals

23. Each of the roles described previously in pharmaceutical industry serve two function: Pharmaceutical Industry Business operations Product development

24. Types of Interactions With Industry Professionals Interactions between industry professions & other part of the medical field usually is related to the business part of the industry Focusing on Pharmaceutical care representatives

25. Types of Interactions With Industry Professionals PSR & health care practitioners PSR & pharmacy/therapeutic committee

26. PSR & Health Care Professionals Goal of PSR: marketing & sale of pharmaceuticals to legal prescribers PSR will need to interact with professionals in regular basis so they must convey information in appropriate manner so basic communication skills are essential Other essential skills companies look for when employing a PSR Interactions

27. PSR & Health Care Professionals Other essential skills companies look for when employing a PSR:  Patience  Diligence  Ability to understand basic medical & pharmaceutical terminology  Organization skills  Acceptable appearance  Ability to accept criticism & deal with it appropriately Interactions

28. PSR & Health Care Professionals During interaction with professionals the PSR offer the latest marketing information about their products Product information is usually distributed in the form of:  Brochures  Medical literature reprints  Multimedia presentations Interactions

29. PSR & Health Care Professionals The health professional expect certain information from the PSR about a certain pharmaceutical product which include:  Indication  Therapeutic benefits  Safety data  Comparative data with new or old drugs  Price Interactions

30. PSR & Health Care Professionals A study was conducted to determine if the physician received these information, the results showed that most of sale representatives focused on indication & giving less information in regard to drug safety, comparable efficacy & cost Pharmacists working in the hospital can help physicians in providing additional information in case PSR did not cover all the aspects Interactions

31. PSR & Health Care Professionals PSR may also distribute drug samples Drug sample: a package containing a limited quantity of pharmaceutical product sufficient to evaluate clinical response, distributed to authorized health care practitioners free of charge & for patients for treatment Interactions

32. PSR & Health Care Professionals Positives & negatives of drug samples: Interactions PositivesNegatives Treatment option for some patient Poor drug control including incorrect labeling & packaging Opportunity to experience a new product for a physician Access to prescription drugs by inappropriate personnel Convenience Encouragement of poor prescription practices

33. PSR & Pharmacy/Therapeutic Committee Sale representatives may be asked to provide information upon request to address specific concerns of the P&T committee Formulary adoption of a particular drug is extremely valuable to the PSR Interactions

34. Medical Liaisons & Thought Leaders MLs deliver medical education message as opposed to marketing message MLs share scientific information about drug products with PSR & instruct them on key points They may give presentation to practitioners MLs have extensive medical background allowing them to have more information about a product Interactions

35. Pharmaceutical Marketing & Patients Companies tend to use DTC (Direct To Consumer) advertisements This makes patient demand the new medication, leading to increase profit Pharmacists specially community pharmacists can help educate the patient if he has any question regarding a drug he saw in an advertisement Interactions

36. Guidance Interactions With Industry Professionals

37. Institutional policies & procedures PhRMA code Food & drug administration (FDA) Others

38. Institutional Policies & Procedures Health institutes generally have policies & procedures related to the activities of PSR within their facility ASHP published a guideline for pharmacists for the activity of PSR Each hospital can have its own policy & procedure Guidance on Interactions

39. PhRMA In 2002 the PhRMA adopted a code for pharmaceutical manufacturers as related to marketing interactions with health care professionals, & specifically the gifts & gratuities given to health care professionals The Code attempts to ensure that all interactions focused on informing healthcare professionals about products, providing scientific & educational information, & supporting medical research & education Guidance on Interactions

40. PhRMA Key points of PhRMA code: Guidance on Interactions CategoryGuidance General interactions The interactions should focus on providing medical educational information EntertainmentShould not be included in interactions, except if there is a venue related to proving scientific information Continuing education Sponsors can provide support for conferences but not individual participants. Sponsors should not be involved specifically with the content GiftsGifts with personal benefit only are not allowed. Items for health care of patients are allowed if less than 100 $. Example of allowed gifts include office pens, notepads & anatomical models

41. FDA In addition to its expected role in drug development the FDA regulate direct to consumer advertising They mandate that these advertisements portray a fair balance for medications this include the major risk of the product Guidance on Interactions

42. Other Career Areas in Pharmaceutical Industry

43. Clinical research administrators Clinical or product development professional Drug discovery professionals Health outcome professionals Project management Quality assurance professional Regulatory professional Scientific communications professionals

44. Drug Discovery Professionals Professionals who are involved in early stages of molecular & chemical identification They usually require more specific skills in areas including but not limited to:  Organic & medicinal chemistry  Pharmacology  Pharmaceutics  Pharmacogenomics…

45. Health Outcome Professionals They are professionals who utilize pharmacoeconomic backgrounds to create models & studies to investigate the benefits of a given pharmaceutical product May be involved in:  Phase IV post-marketing studies  Discuss economic considerations at their institute  Or utilize this information when making formulary decisions

46. Quality Assurance Professional They are different than quality control professionals (quality control professionals test chemical products & evaluate manufacturing processes) Quality assurance professionals work with:  Clinical development  Training & development  Regulatory components of the company To assure that business operations function at an acceptable level of quality

47. Regulatory Professionals Interact with regulatory agencies throughout the world Unlike legal department, regulatory professionals are more likely to have science & medical backgrounds They must have an understating of the medical environment & how a product might position it self in the market They must be able to communicate scientific & medical information to regulators to support positive product approval

48. Summary Pharmaceutical industry carries different career pathways for pharmacists & open new work ideas The relationship between the industry & healthcare professionals is mostly done through marketing or advertising agents This relationship has its own guidance & protocol to prevent bias

49. Thank you